Recent upgrades in international and domestic regulations regarding clinical trials, are both designed to protect patients, but also to upgrade the ‘new normal’ procedures in clinical trial quality and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting. Internationally, the key regulation is Good Clinical Practice, which is: “Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.”  Active Healthcare companies in the markets this week include: Soliton, Inc.(NASDAQ: SOLY), ViewRay, Inc. (NASDAQ: VRAY), PAVmed Inc. (NASDAQ: PAVM), Corindus Vascular Robotics, Inc. (NYSE: CVRS), Teva Pharmaceutical Industries Limited (NYSE: TEVA).

A respected industry source added that they feel that “technology increases efficiency” and feels that if clinical trials are conducted using new compliant technology, that is also reduce cost of the trials and could also shorten the time to market.  And by following these regulations, the FDA is also providing a faster pathway in the U.S.. A Forbes article discussed this new pathway: “In an ever-changing healthcare  landscape, FDA seeks a new procedure that will let the market continue to develop but also offer a safe environment for the users. “The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health,” said FDA Commissioner Scott Gottlieb. The move comes shortly after the FDA announced plans to modernize the medical device 510(k) clearance pathway; The De Novo device classification requests should help market applicants better determine whether to utilize this registration pathway given its significant cost.

Soliton, Inc. (NASDAQ: SOLY) BREAKING NEWS:  Soliton, a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), highlights the Company’s important partnership with Sanmina Corporation (Nasdaq: SANM) to advance its acoustic shockwave technology into the commercialization phase in preparation for product launch.

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Sanmina is a global contract electronics manufacturer and one of the world’s largest medical device manufacturers.  Under the agreement, Sanmina will provide the design and testing to advance Soliton’s RAP device for use in future clinical trials and eventually to lay the foundation for a commercial launch of the Company’s products.

“Working with Sanmina in this commercialization phase not only provides us with world-class quality and documentation,” commented Dr. Chris Capelli, Soliton’s CEO, “but we also believe it will make for a smoother transition to manufacturing, which we expect to begin here in the US later this year.”    Read this and more news for SOLY at:  https://www.financialnewsmedia.com/news-soly/